Feasibility Study to Assess a Trans-nasal Intestinal Potential Difference Probe

Study Purpose

The purpose of this study is to examine the feasibility of using a trans-nasal IPD probe as a measurement tool for gut permeability

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years - 60 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Healthy subjects.
  • - Subject must be 18 to 60 years of age.
  • - Subject must be able to consent to the procedure.
  • - Subject must fast (no solid food) for at least 8 hours prior to the procedure.

Exclusion Criteria:

  • - Subjects with a history of upper respiratory disease or surgery.
  • - Subjects with a history of upper gastrointestinal surgery.
  • - Subjects with upper respiratory infection at least 7 days prior to the procedure.
  • - Subjects with any contraindications to the placement of the NJ tube including deviated septum or any other anatomical abnormalities of the nasopharynx or upper gastrointestinal region, history of trans-sphenoidal surgery, facial or cranial trauma and fractures, chronic sinusitis, esophageal strictures, varices etc. - Subjects with a history of or being on medications that delay gastric emptying.
  • - Subjects on drugs which impair clotting like anticoagulants and antiplatelet drugs, NSAIDS, history of bleeding disorders.
  • - Subjects using nasal steroids or any steroids for environmental allergies.
  • - Subjects with suspected or diagnosed HIV.
  • - Subjects with a recent use of Antibiotics within the past 4 weeks.
  • - Subjects with a current or history of Alcoholism.
  • - Subjects with suspected or diagnosed Hep B or Hep C.
  • - Subjects with suspected or diagnosed Galactosemia.
  • - Subjects enrolled in clinical trials involving interventions that affect Intestinal Permeability.
  • - Subjects with uncontrolled Diabetes Mellitus 1 & Diabetes Mellitus 2.
  • - Subjects currently taking H2 Histamine Antagonists (such as Pepcid, Axid, Tagamet, Zantac, etc) - Subjects currently taking Mast Cell stabilizers.
  • - Subjects currently Lactating due to Pregnancy.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Massachusetts General Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Guillermo Tearney, M.D, PhD.
Principal Investigator Affiliation Massachusetts General Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Inflammatory Disease, Permeability; Increased, Crohn Disease, Inflammatory Bowel Diseases, Environmental Enteropathy
Additional Details

Increased gastrointestinal (GI) permeability is associated to several GI conditions that affect millions of people worldwide. Healthy intestinal walls limit only specific molecules to cross into the body. "Leaky gut" is a condition of unregulated and increased gut permeability that allows unwanted antigens, pathogens and microbial toxins into the bloodstream(1). This in turn leads to a subsequent immune response that includes the production of inflammatory mediators. Leaky gut is a key feature in celiac disease, Crohn's disease, inflammatory bowel disease (IBD), and environmental enteropathy and have been associated with systemic diseases including type 1 diabetes, autoimmune hepatitis, and systemic lupus erythematosus (SLE). The current gold standard for measuring intestinal permeability is the sugar ratio test. Non-metabolized sugars of different molecular sizes are orally administered and the amount of sugar molecules absorbable across the gut lining is then quantified by measuring their relative concentrations in urine. In healthy subjects, low to none of the large-molecule disaccharides can be taken into the circulatory system, while the small-molecule monosaccharides can readily diffuse into the bloodstream. This results in low disaccharide/monosaccharide (DM) ratios for healthy subjects. Subjects with the leaky gut conditions exhibit high DM ratios in their urine. However, the sugar ratio test has low specificity, does not provide specific information on etiology, is challenging to implement when pristine urine samples cannot be collected (e.g. infants), and does not account for spatially heterogeneous disease. An alternative approach for measuring mucosal permeability is through measuring the voltage across the intestinal wall (Intestinal potential difference; IPD) that changes with intestinal permeability. The Tearney lab has developed an IPD measuring device (IPD probe) that can be deployed trans-nasally and can measure the intestinal potential difference in real time at selected locations of the gut. The probe contains a central channel that allows us to infuse specific ionic solutions into the gut. The IPD probe also has an optical fiber inside the channel that enables the acquisition of M-mode OCT images. The M-mode OCT images make it possible to determine when the IPD probe is in contact with the tissue.

Arms & Interventions


Experimental: Feasibility of trans-nasal IPD probe

The purpose of this study is to examine the feasibility of using a trans-nasal IPD probe as a measurement tool for gut permeability


Device: - IPD Probe via TNIT

A total of 10 healthy adult volunteers will be enrolled in this study. All consented participants will be receive the same intervention. A Nasal tube will be inserted through nares until reaching the small intestine. This will be confirmed by m-mode OCT. Once secured, we will start infusing Ionic solution into the intestine so that IPD Probe can measure the potential difference between this and the control reading. The control reading is measured by infusing the same ionic solution subcutaneously on large muscle groups.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Massachusetts General Hospital, Boston, Massachusetts




Massachusetts General Hospital

Boston, Massachusetts, 02114

Site Contact

Anita Chung, RN